Streamlining Registry/IRB Review Process: Templated Application and Central IRB

1. Castine Clerkin VPR Program Manager June 12, 2019 Status of the Templated IRB/Registry Application, Implementation of the Central IRB and Local Context Issues

2. Today’s Talk • Why and how to streamline registry/IRB review process • Adoption of Templated IRB/Registry Application (TIRA) • Status of Central IRB Efforts

3. Why Streamline? • Each registry and IRB has a different application process • Requesting linkages with 50 registries takes significant time • Each registry and IRB reviews the same study • Review time can take a few weeks to over a year • Due to varying approval timeframes, data from registries is released to researcher sporadically, over extended period • Delayed completion of studies

4. Approach to Streamlining Application & Review • The VPR-CLS will streamline the process using: • Templated IRB/Registry Application (TIRA) • Single form to be used in lieu of state-specific forms • Created by review of 50+ IRB and registry applications • NCI Central IRB (CIRB) • Single IRB for review of minimal risk, multi-site studies • Used in lieu of local/state IRB review • Both are voluntary

5. TIRA - Templated IRB/Registry Application • Fall 2018: Vetted with registries • Reviewed all comments and modified TIRA • Winter 2019: Vetted revision with the 38 VPR pilot test registries and their IRBs • Identify and address any issues that would limit use of the TIRA • Get final determination about whether state IRB and/or registry could use TIRA in Phase II of VPR pilot testing • Assign all states to a category

6. Use of TIRA by VPR pilot test registries (n=38*) State IRB Registry Templated Application (TIRA) & or 9 with 2 forms State- specific IRB or & or State specific Reg form *One pilot test registry cannot participate in Phase II requests for individual-level data • 73% of respondents can use TIRA only • 84% of respondents can use TIRA for some aspect of review • Use of TIRA will eliminate the need to fill out 40 different applications!

7. Use of a Central IRB (CIRB) for Minimal Risk Study Reviews Steve Friedman, Annelie Landgren Surveillance Research Program, NCI NAACCR Annual Conference

8. Background for CIRB procurement New policies for NIH funded studies • NIH policy, effective 1/20/20, stipulates that a Single IRB (sIRB) or record will be used for multi-site studies. • This policy brings NIH into compliance with changes to Common Rule Decision made by NCI for VPR use • To pursue procurement of a commercial IRB to serve as a Central IRB (CIRB) with focus on Minimal risk registry linkages. AAHRPP Accreditation required • Costs for this CIRB procurement supported by NCI NCI Objective of establishing a CIRB: • Provide a CIRB for the review of minimal risk, multi-site studies to help alleviate the burden on both the registries and the investigators in review of multiple IRBs • Provide access to IRB review for those registries who do not hold an IRB

9. Requirement for the CIRB procurement AAHRRPAccredited - Association for the Accreditation of Human Research Protection Programs (non-profit accrediting body) Benefits of accreditation: • helps organization adhere to OHRP and FDA requirements • part of organizational quality efforts and demonstration of commitment to patient safety through adherence of industry leading standards

10. Benefits of a CIRB review of multi-registry linkage studies Benefit to Investigator • Eliminate duplicative IRB review (beyond initial institutional IRB approval) • Reduce timeline for approval and release of data • Central CIRB communication with Investigators/Registries via the VPR-CLS System Benefit to Registry • Decrease administrative burden on research and registry staff • Increase use of registry data Benefit to local IRB • Ensure consistency of IRB reviews • Reduce effort by local IRBs to manage and review minimal risk protocols and free up time and resources for other reviews • Reduce local/state requests for protocol changes that necessitate re-review by institutional IRB

11. Studies eligible for linkage using VPR-CLS Minimal Risk Linkage Studies eligible for VPR: • Established cohorts • Institutional IRB approval prior to application • IRB-approved protocol includes linkage with cancer registries • Study consent form includes linkage with registries OR study has a waiver of informed consent

12. Division of IRB Responsibilities

13. Workflow, context and local requirements for accepting the CIRB

14. VPR Phase II Workflow (including CIRB) • Phase I • institutional IRB approval of linkage • researcher has all match counts • Phase II • Researcher selects registries • VPR liaisons has access (VPR-CLS) • Local processes in parallel CIRB sends approval notification through VPR-CLS to all involved parties and uploads approval documents CIRB reviews application PI submits completed CIRB application (using TIRA) Pre-Review CIRB Approved Yes OK No No Feedback to PI with instructions if applicable CIRB sends notification to PI with instructions if applicable

15. What to consider when setting up the CIRB Aiming for a variation of responses - we approached representatives from 9 state registries (their IRB if applicable) With IRBs located at: • A University • The State health department

16. Alleviate three common concerns from Registries • Will we have final say on what is released? • Will we know what is going on? • How will our data be protected and used?

17. Alleviate three common concerns from Registries Registries have final say on what is released • After a CIRB approval, the registries will adhere to their local rules on what data variables will actually be released even if this means not releasing or change extent of release (e.g. full date to year only). Transparency – selected registries • Registry Liaisons have full access to study and application documents Investigators have submitted through the VPR-CLS regardless of who performs the review. • Registry Liaisons will be ensuring local tracking/other required procedures takes place in parallel with VPR-CLS/CIRB review. Data Use Agreements (DUA) remain between registry and researcher • For the time being DUAs will be negotiated with each participating registry (before or after other reviews as needed) • Will address registry–specific requirements for data use, re-release, storage, destruction, etc.

18. Questions discussed with 9 registries (and any IRBs) • Local IRB review requirements: • Is a local IRB review required in the state? • How is research participation by registry staff defined and does this change local IRB requirements? • Would VPR studies be considered human vs. non-human research? • Ability to delegate review authority to CIRB • Did they have experience delegating IRB previously? How was it done? • Type of Agreements needed • What type of mechanism (MOU, reliance agreement, etc.)? • Factors limiting CIRB use • Is anything needed to facilitate CIRB use?

19. Summary of discussions with 9 registries (and any IRBs) General • Level of acceptance/comfort with CIRB increased • with knowledge of final autonomy on what data items to release • once CIRB benefits, workflow and level of transparency clarified • Generally supportive, but need to know more about CIRB first Ability to delegate review authority to CIRB • Differing views about what requires IRB review • Some have done this on a study-by-study basis • Importance of CIRB addressing local context issues Type of agreement/mechanism needed • Varied from state to state (memorandum of understanding, reliance agreement, etc.)

20. In conclusion The CIRB will work with each local IRB • to determine which, if any, agreements are needed Also Inability to use CIRB will not exclude registry from participation in VPR linkages even if it remains a long-term goal that most registries will.

21. CIRB Contract Tasks Major Tasks for the CIRB Contractor Include: • CIRB will work with local IRBs to put mechanisms in place to be the IRB of record. • Preferably umbrella approvals (i.e., for all minimal risk studies within the IRBs purview) • Have process and SOPs for the review and adjudication of expedited reviews of minimal risk studies Identify reviewers for expedited reviews (Chair/Reviewers)- Handle communications with PIs regarding reviews • Ability to adjust to increased capacity based upon demand • Store and manage all review related materials securely • Promote/provide information regarding VPR-CLS on their website • Educate those involved on CIRB process to enhance submission/review effort • Communicate through the VPR-CLS

22. Status and Next Steps for CIRB Contract • Industry day to be held to increase awareness and interest in the solicitation • Modify SOW based on industry day input • Issue solicitation • Make award

23. Summary • Cost of CIRB Contract supported by NCI • Use of CIRB and TIRA is voluntary • Registries and IRBs have been receptive to CIRB and TIRA • Adoption of TIRA, and CIRB when established, will help researcher, registries, and local/state IRBs. • Inability to accept them does not exclude a registry from participating VPR linkages • Anticipate increased acceptance of TIRA and CIRB with time, education and comfort-level